Title

New researchers

Applying to do research at VA Pittsburgh

Are you conducting research?

Does the project you are proposing constitute research? In order to constitute research both of the following must be true:
(a) The activity is a systematic investigation, including research development, testing and evaluation
(b) The activity is designed to develop or contribute to generalizable knowledge.
If the answer to both of these questions is yes, is this research being conducted by VA investigators on VA time, utilizing VA resources, or being conducted on VA property?
If the answer to "b" is yes, proceed to Step 2.
If the answer to "a" or "b" is no, review by a VAPHS Research Review Committee is not necessary.
If you are uncertain as to whether or not the proposed activity constitutes research, please visit the Human Research page and refer to the QA/QI project section for additional guidance.

Employment, training, and credentialing Verification

In order to conduct research at VAPHS, all staff must hold VA appointments (Without Compensation (WOC), VA full-time or part-time, and must be appropriately trained and credentialed. Contact Stephanie Partee to initiate this process.

Submission to subcommittee(s)

All research must be reviewed by at least one of the VAPHS Research and Development Committee subcommittees. There are 4 subcommittees charged with the review of research at VAPHS: The VAPHS Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), and the Research Scientific Evaluation Committee (RSEC). Please see below for additional information regarding your next steps:

For Animal Research being submitted to the VAPHS IACUC: Please contact Beth Toth.
For Human Subjects Research utilizing the VA Central IRB: Please contact Kathy Parks.
For Human Subjects Research projects utilizing the VAPHS IRB: You must register for a ProSPECT account. ProSPECT is the online submission system used for Human Subjects Research and projects which require a not human subjects determination. To Register, access ProSPECT. Please note that ProSPECT is only accessible via VPN and/or government issued equipment as it is housed behind the VA firewall. Specific questions regarding ProSPECT may be directed to the ProSPECT Support Team. Initial questions regarding the submission process may be directed to the IRB Staff.
If your project contains both animal and human subjects components please register for ProSPECT and contact Beth Toth.
If you believe your project is research, but does not involve human subjects or animal subjects, you will need to submit to the VAPHS IRB for a not human subjects determination. These projects are submitted via ProSPECT. You must register for a ProSPECT account to initiate your submission. Initial questions regarding the submission process may be directed to the IRB Staff.

Project review and determination

The appropriate review committee(s) will evaluate your submission and make a determination regarding the status of your project.

Research and development committee review

Once your project is approved by the appropriate subcommittee(s), it will be forwarded to the R&D Committee for approval.

Associate Chief of Staff for Research and Development (ACOS/R&D) notification

The ACOS for Research and Development or his/her designee must ensure that you have received all appropriate approvals. You will be notified in writing (by the ACOS) when all approvals have been granted.

Once all required approvals have been received (all subcommittee, R&D Committee, any other applicable committee/entity, and ACOS/R&D), you may begin your project.

Human subjects research

VAPHS IRB office information

Email: vhapthIRB@va.gov
Phone: 412-360-2384
Fax: 412-360-2385

Research and Development Office

Research Office Building
Mail Code: 151
University Drive, PA 15240

Fax: 412-360-2377

Questions about ProSPECT?

Please contact the IRB Office staff or email the ProSPECT Support Team.

VAPHS staff training requirements

Human Subjects Research is defined as:

Research involving the collection of data through intervention or interaction with living individuals or the collection of identifiable private information (or specimens) from such persons.

With the exception of animal research proposals, all new submissions are initially reviewed by the VAPHS Institutional Review Board (IRB) to determine whether or not the proposal meets the definition of human subjects research or if a "Not Human Subjects Determination" is appropriate.

The IRB also reviews Quality Improvement/Quality Assurance (QA/QI) projects and requests for Reviews Preparatory to Research.

If you are unsure if your project requires review by the IRB, please contact the IRB Office for assistance.

VAPHS IRB submission information

New submissions

All new research protocols involving human subjects (including Full Board, Expedited and Exempt studies) and those which do not include animal subjects must be submitted using ProSPECT (Protocol Submission Portal and Electronic Communication Tracker), the online submission system at VAPHS. Any project deemed Human Subjects will be reviewed by the IRB. Any project that is deemed not human subjects, will be forwarded on to the proper review committee(s).

Other activities reviewed by VAPHS IRB

Quality Assurance/Quality Improvement (QA/QI) Projects and Other Operational Activities

These types of projects are generally undertaken by a service line or department to evaluate the quality of a particular procedure or process. QA/QI projects and Operational Activities are not considered research, however, there are times at which the lines between QA/QI/Operational Activities and Research may become blurred.

Therefore it is suggested that you review the QA/QI Policy as well as the VAPHS Guidance on Operational Activities versus Research to help you determine whether your project is research or not. If you have any doubt as to the status of a project, you should submit a copy of the Operations Activity Worksheet, along with the materials requested on the form to the IRB for a formal determination.

Reviews preparatory to research

Reviews preparatory to research are generally small reviews (NOT PILOT PROJECTS) conducted in preparation for a research project in which access to personally identifiable information is needed in order to design a research study or assess the feasibility of conducting a study. Individuals interested in conducting a review preparatory to research should follow the Guidance on Reviews Preparatory to Research.

Committee member information

Questions regarding the VAPHS Research Review Committees should be directed to the appropriate committee coordinator:

For R&D Committee questions contact:
Genna Mauro
Phone: 412-360-2386

For IRB Committee questions, contact:
VHAPTHlRB@va.gov

For IACUC or IBC questions, contact:
Beth Toth
Phone: 412-360-2382

For RSEC questions, contact:
Stephanie Partee
Phone: 412-360-2386

For general research/education questions, contact: VHAPTHRESEARCHEDUPOLICY@va.gov

Committee member training requirements

This page is intended for members of the following VAPHS Research Review Committees:

Research and Development (R&D) Committee
VAPHS Institutional Review Board (IRB)
Institutional Biosafety Committee (IBC)
Institutional Animal Care and Use Committee (IACUC)
Research Scientific Evaluation Committee (RSEC)

Contact us

Research and Development Office
Research Office Building #30
Mail code: 151
University Drive
Pittsburgh, PA 15240